The present invention relates to alarm and data logging apparatus. More particularly, the invention relates to a preferably self-contained apparatus for issuing alarms and recording the results of regularly scheduled breast self-examinations, conducted by a woman at a pre-determined optimum time each month.
The incidence of breast cancer has reached near epidemic proportions in certain areas of the world. In the United States breast cancer in woman is among the most commonly discovered malignant tumor, and it is the leading cause of death by cancer. In several regions of the world, a significant increase has been documented wherein at least 1 woman in 10 will have a breast cancer related event before the age of 60.
Importantly, researchers have determined that the earlier cancer is detected, the smaller the size of the discovered tumor, and the greater the number of years one can expect to be cancer free. Simply put, early detection leads to a greatly increased survival rate and subsequent cancer-free life span.
At present, there are a number of well known and accepted methods available for detecting and diagnosing breast related abnormalities. For example, the ubiquitous mammography, which is an x-ray based imaging technique, is employed by large numbers of woman on a regular annual or semi-annual basis. Also, recently improved sonar based imaging apparatus are also utilized. Each of these techniques involves an imaging of a woman""s breasts to aid in detecting small, possibly non-palpable, lumps and abnormalities.
Many doctors also strongly recommend that woman perform regular monthly breast self-examinations. Self-examinations are particularly desirable for woman with a history of breast cancer and pre-cancer related events, as an abnormality may be discovered months before a next periodic imaging (e.g., mammography) appointment. Breast self-examination (BSE) represents a simple, fast, and inexpensive method, easily performed at home or in a private setting, that enables early detection of lumps, tumors, and other abnormalities. It has been documented that 10 to 15 percent of palpable tumors fail to be detected by mammography. In addition, when considering women who conduct BSE frequently, say on a monthly basis, the size of detected tumors has been determined to be significantly smaller (by almost 50%) than those women who don""t regularly perform BSE.
Even with all of the above known and well understood by most women, many would attest to the difficulty of performing BSE on a truly regular and consistent basis. First, BSE is best performed 7 to 10 days after the conclusion of a woman""s menstrual cycle. This is much more difficult to remember and time than if the BSE was best conducted during the menstrual period. In addition, even if the BSE is performed, most women don""t record important information related to possible breast abnormalities, and where they were detected. Should an abnormality be detected, it is not unusual for a woman to delay one or more months before contacting their Doctor. A natural xe2x80x98denialxe2x80x99 period can be expected in many women. As a result, time and information, which may prove helpful to a physician, is lost!
Accordingly, it would be most desirable to have an apparatus, which may most preferably be fully self-contained, that enables a quick and easy programming so as to remind a woman to perform BSE at an appropriate time of each month. The apparatus would be structured to enable quick and easy recording and archiving of the results of each BSE performed periodically over a long period of time. A number of other characteristics, advantages, and or associated novel features of the present invention, will become clear from the description and figures provided herein. Attention is called to the fact, however, that the drawings are illustrative only. In particular, the embodiments included and described, have been chosen in order to best explain the principles, features, and characteristics of the invention, and its practical application, to thereby enable skilled persons to best utilize the invention and a wide variety of embodiments providable that are based on these principles, features, and characteristics. Accordingly, all variations possible are contemplated as being part of the invention, limited only by the scope of the appended claims.
In accordance with the present invention, an apparatus for issuing alarms and recording results of regularly scheduled breast self-examinations (BSE) is provided. Importantly, the apparatus is intended to remind and encourage that BSE be performed by a woman during a pre-determined optimal temporal interval of each of a succession of months. It may be noted that a pre-determined temporal interval is calculated and determined for each of a plurality of months using information provided by the woman during a setup and initializing of the apparatus, or information later provided, for example, at the start of a menstrual cycle.
The apparatus is configured with a controller or a computer including a portion for determining the present time and date, which has also been termed a xe2x80x98temporal momentxe2x80x99. For example, the computer may include an electronic circuit, or equivalent software functions, that provide for a calendar/clock function. The calendar/clock enables the computer to determine when a pre-selected temporal moment has been reached. That is, to determine when a BSE is due to be conducted. The apparatus is further structured with a human interface that is operatively and functionally coupled to the computer. The human interface enables, among other functions, an exchanging of information with one or more women related to the setting up and initializing of the apparatus, as well as the issuing and responding to alarms related to temporal intervals during which a BSE is to be performed.
Another aspect of the apparatus provides for a database, preferably provided by and/or supported by the computer. Alternately, a remote computer to which a link may be established may provide access to a suitable database. In any possible situation, the database is available to a processor of the computer and structured to enable the computer to determine when a pre-selected temporal interval for each month has been reached so as to support the issuing of the above mentioned alarms. The human interface may be structured to include at least one of an audio module, for providing audio information to the woman including one of audio tones and voice alarms, and a vibration unit that may be energized by the computer for providing a substantially silent alarm to the woman, as required. It may be noted that the terms xe2x80x98monthxe2x80x99, xe2x80x98monthlyxe2x80x99, and equivalents, are intended to be broadly defined as a repeating periodic interval, possibly having a period that varies slightly, and repeats. Therefore, a monthly interval, as determined by a woman""s actual menstrual cycle may actually be less than or greater than 30 days for a given cycle/month.
The human interface would most preferably include means that readily enables a woman to update previously input information. For example, the updated information may include, among other items, at least one of a starting date of a past or present menstrual cycle, a duration of an actual past or present menstrual cycle, an average number of days before the start of a next menstrual cycle, etc. Such an updating of these items may be applied for calculating, updating, and storing for future use, a variety of alarm dates at which time an alarm is to be issued to the woman indicating that a self-examination is to be conducted.
An important aspect of the present invention is that during a setting up of the apparatus a woman may provide actual information based on one or more past menstrual cycles, or estimated information when actual exact dates, etc., are not known or available. In addition, the woman may input a combination of actual and estimated information. When considering this feature, an xe2x80x98updatexe2x80x99 command, for example one similar to that taught by Jacober et al., in U.S. Pat. No. 5,657,753, may be employed. Such a feature would enable a woman to correct or re-align the calculated alarm dates, including the next alarm to be issued, based on an unexpected early or delayed start and or end of a menstrual cycle. However, the present apparatus will enable a somewhat detailed and archived record of each of a succession of breast self-examinations performed to be available to individuals, even years after they are conducted. This archiving and long term storage of results is an important feature supported by embodiments of the invention.